Conceptus Reports First Quarter 1999 Financial and Operational Results; Reports Results From Phase II Study of S/TOP Transcervical Permanent Contraception Device
SAN CARLOS, Calif.--(BW HealthWire)--May 21, 1999--Conceptus, Inc. (Nasdaq:CPTS) announced today the financial results for its first quarter of 1999.
The Company reported first quarter net sales of $30,000, compared to sales of $167,000 over the same period last year. The Company also reported a net loss of $1,081,000 or $0.11 loss per share for the first quarter compared with a net loss of $3,456,000, or $0.36 loss per share for the same period last year. Cash and equivalents at the end of March were approximately $16.0 million.
"This was a very important quarter for Conceptus. Although we have reduced our spending significantly since last year, during the quarter we made excellent progress in our S/TOP(TM) transcervical permanent contraception program, which represents the highest-value clinical application of our unique Transcervical Tubal Access Catheter (T-TAC) technology platform," stated Kathryn Tunstall, Conceptus's President and CEO.
"S/TOP is designed to be a non-surgical alternative to one of the most common and rapidly growing medical procedures: surgical female permanent contraception or tubal ligation." The market for a non-surgical method of permanent contraception is considered to be one of the largest medical device markets.
Mid-year 1998, Conceptus effected a major restructuring which reduced headcount and spending by more than two-thirds, and focused its remaining resources on the S/TOP program. At the time of restructuring the Company set certain milestones for the STOP program. By July 1, 1999, Conceptus planned to (1) modify the S/TOP device which had been used in pre-clinical and early clinical studies (2) successfully place the device in twenty patients desirous of permanent contraception in a Phase II study of safety and feasibility, (3) demonstrate that the S/TOP procedure can be performed quickly and without general anesthesia, (4) obtain sixty woman-months of efficacy data from patients in which the STOP device was placed, and (5) obtain histological evidence of the theorized mechanism of action of S/TOP.
"I am pleased to report the first results from our Phase II study of safety and feasibility of S/TOP," stated Tunstall. "I can also report that as of May 1, 1999 we had achieved each of the milestones we set for the program last summer," added Tunstall, "fully two months ahead of plan."
During first quarter, 1999, the Company received FDA approval of an Investigational Device Exemption (IDE) amendment to began clinically evaluating the gamma version of the S/TOP proprietary micro-coil device in US Phase II studies. The Gamma design addresses several performance issues identified during early clinical study of alpha and beta configurations of the S/TOP device, and has been successfully used in Australian studies since November 1998.
The gamma design improves retention in order to reduce the possibility of expulsion or migration of the device and increases the ease of placement of the S/TOP device which reduces procedural time. To date, Conceptus has achieved successful gamma placement in 88% of fallopian tubes attempted, and in the last twenty out of 32 patients treated with the gamma device, 100% bi-lateral tubal placement has been achieved. The Company has not experienced migration or expulsion of gamma devices in 32 patient placements.
In order for the S/TOP procedure to be accepted as an alternative to surgical tubal ligation, the most common form of contraception used worldwide, the S/TOP procedure, like other typical gynecological office procedures, must be able to be performed quickly and with minimal anesthesia. In Conceptus's Phase II study to date, bilateral S/TOP device placement has been achieved in a total of 44 patients (12 beta, 32 gamma).
The average time of procedure in all cases was 30 minutes; gamma device procedures averaged 20 minutes. In the majority of cases, study physicians administered a combination of local anesthetic, light anesthesia, and an analgesic, all of which are frequently administered during other office-based gynecological procedures. Thus far, 83% of patients rated the level of procedural comfort as good to excellent.
In early May 1999, the milestone of obtaining 60 woman-months of efficacy data was achieved. There have been no pregnancies to date. Although a large pivotal study will be required in order to support a claim of permanent contraception, the Company's statisticians report that if S/TOP were not having a contraceptive effect, the expected number of pregnancies in the study to date would have been approximately 5. The Company has also obtained more than 120 woman-months of "wearing" data from the study.
Conceptus has continued to conduct parallel studies of the mechanism of contraceptive action of S/TOP in pre-hysterectomy patients. The mechanism of contraception of S/TOP is theorized to be a result of both the space-filling design of the device as well as a local inflammatory tubal-tissue response to the device, which mechanically alters the tubal architecture and interferes with the function of the normal fallopian tube.
Histological review of 35 fallopian tubes in which the S/TOP device was placed for an average of 9 weeks is supportive of this hypothesis. Both beta and gamma configurations were represented in this study.
"Our physician investigators are very excited about the progress made in the S/TOP transcervical permanent contraceptive program and, importantly, patient satisfaction with the procedure is high." stated Tunstall. Compared to surgical sterilization, study patients have described S/TOP as "more natural" and less disruptive of their busy lives. Tunstall related the comments of one patient in Australia (where the Phase II study began), "I didn't even have to hire a baby-sitter in order to have a sterilization procedure."
Conceptus has also experienced a strong response to outreach activities designed to recruit patients for the Phase II study. A press conference held by the lead Australian S/TOP investigator was the impetus for over 350 phone calls from patients interested in enrollment in the study.
The Company intends to begin a Pivotal efficacy study of S/TOP outside the US later this year, and will submit an IDE in 1999 to the FDA to begin Pivotal trials in the US in early 2000. The Company intends to step up spending significantly in order to support its expanded Phase II and Pivotal trials, however Conceptus does not at this time anticipate needing to raise additional capital to complete enrollment of the S/TOP pivotal study.
Conceptus, Inc. designs and develops innovative interventional medical devices for use in reproductive medicine. The Company has developed the STARRT Falloposcopy and T-TAC catheter systems to improve the diagnosis and treatment of fallopian tube diseases and disorders, a primary cause of infertility.
The Company has also developed the ERA Resectoscope Sleeve, incorporating novel technology designed to improve the safety and ease-of-use of therapeutic hysteroscopy, a growing, less-invasive alternative to hysterectomy. Conceptus is in Phase II clinical trials of its S/TOP permanent contraception system, a non-surgical approach to fallopian tube sterilization, which is the most commonly performed contraceptive procedure worldwide.
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. The receipt of regulatory approvals, results of product development programs, clinical efficacy of and market demand for products, among other matters discussed in this release, may differ significantly from the discussion of such matters in the forward-looking statements. Such differences may be based upon factors within Conspectus's control, such as strategic planning decisions by management and re-allocation of internal resources, or on factors outside of Conspectus's control, such as delays by regulatory authorities, scientific advances by Conceptus or third parties and introduction of competitive products, as well as those factors set forth in the Company's quarterly report on Form 10-Q for the quarter ended September 30, 1998, its Annual Report on Form 10-K for the year ended December 31, 1997 and other filings with the Securities and Exchange Commission.
CONTACT:
Conceptus, Inc.
Oliver Brouse, 650/802-7240
KEYWORD: CALIFORNIA
BW0240 MAY 21,1999
17:15 PACIFIC
20:15 EASTERN |
